| Primary Device ID | E29951269 |
| NIH Device Record Key | efb4b59c-95ab-4417-8987-52b98f61ba80 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | maximat plus pre-loaded |
| Version Model Number | 5126 |
| Company DUNS | 481461598 |
| Company Name | Polydentia SA |
| Device Count | 30 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch | |
| Phone | +41919462948 |
| info@polydentia.ch |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E29951260 [Primary] |
| HIBCC | E29951269 [Unit of Use] |
| DZN | Instruments, Dental Hand |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-13 |
| Device Publish Date | 2022-07-05 |
| E29951269 | metal matrices 0.025 mm / 6.3 mm |
| E29951259 | metal matrices 0.025 mm / 5.5 mm |
| E29951249 | metal matrices 0.04 mm / 6.3 mm |
| E29951239 | metal matrices 0.04 mm / 5.5 mm |